BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE BLANKET

    MDR report key: 6734857 · Received July 23, 2017

    Report

    Report Number
    3018859-2017-00501
    Event Type
    Malfunction
    Date Received
    July 23, 2017
    Report Date
    June 23, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K163589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NATUS TECHNICAL SERVICE MADE MULTIPLE ATTEMPTS TO CONTACT THE COMPLAINANT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE (INCLUDING WHETHER THERE WAS ANY DISCOLORATION OR DEGRADATION OF THE LIGHT PAD) AND TO REQUEST RETURN OF THE LIGHT PAD. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED BECAUSE NO RESPONSE TO THESE COMMUNICATIONS WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE ISSUE WAS VERIFIED BY NATUS TECH SUPPORT OVER THE PHONE WITH THE CUSTOMER. THE CUSTOMER SAID THEY PLUGGED IN A DIFFERENT LIGHT PAD, AND IT WORKED PROPERLY THE INTENSITY MEASURED WITHIN RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS 2+ YEARS OLD DEVICE TO DETERMINE THE CAUSE FOR THE LOW INTENSITY ISSUE. TECH SUPPORT ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER AND RECEIVED NO RESPONSE. DOC-0015346 REV B ID E60 LIGHT BOX DELIVERS TOO LITTLE IRRADIANCE, SEVERITY RATING IS 3 (MODERATE), RISK RATING IS LOW. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS ON (B)(6) 2017 THEIR NEOBLUE BLANKET LARGE PAD, PN: 006245, SN: NA, LOT: N072314-05 AND INSTALLED: 10/28/2014. THE LIGHT PAD WAS DIM AND THE OUTPUT INTENSITY WAS MEASURING LOW. THE CUSTOMER DOESN'T RECALL THE OUTPUT INTENSITY READINGS AND THE PHOTOMETER USED TO MEASURE THE INTENSITY. THE CUSTOMER CONFIRMED THERE WAS NO DEATH/SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515228 NEOBLUE BLANKET NEOBLUE BLANKET LBI NATUS MEDICAL INCORPORATED 006245 N072314-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O